Recall of Similasan iVIZIA Sterile Lubricant Eye Drops

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Thea Pharma, Inc. is voluntarily recalling specific lots of Similasan iVIZIA Sterile Lubricant Eye Drops due to a lack of assurance of sterility identified by FDA inspections.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Thea Pharma, Inc. is recalling certain lots of Similasan iVIZIA Sterile Lubricant Eye Drops because of a lack of assurance of sterility, stemming from CGMP deviations found by the FDA during an inspection of the manufacturer.

Which Products Are Affected

The affected product is Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, with NDC 59262-700-11. The specific lots are Lot# 5S30B and 5S30C with an expiration date of April 30, 2026, and Lot# 5S31B and 6S57B with an expiration date of May 31, 2026. The recall affects products distributed nationwide within the United States, with no specific quantity provided.

What You Should Do

Consumers who have the affected products should follow the initial firm notification, which was issued via letter, and contact Thea Pharma, Inc. for instructions on returns or refunds. No specific contact information is provided in the recall details.

Why This Matters

This recall highlights potential risks associated with non-sterile eye drops, which could affect product safety for consumers relying on these items for eye care. It underscores the importance of maintaining proper manufacturing standards to ensure public health.

Source

This information is from the FDA recall notice, recall number D-0501-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Thea Pharma, Inc. is voluntarily recalling specific lots of Similasan iVIZIA Sterile Lubricant Eye Drops due to a lack of assurance of sterility identified by FDA inspections.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.